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K Number
K113823
Device Name
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
Manufacturer
THE BINDING SITE GROUP LTD
Date Cleared
2013-03-27

(456 days)

Product Code
CFN,PDE,PDF
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
K140686
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hevylite™ Human IgM Kappa Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Kappa (combined u heavy and K light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemiain conjunction with other clinical and laboratory findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macroglbulinaemia.

Hevylite™ Human IgM Lambda Kit for use on Siemens BN™II is intended for the in vitro quantification of IgM Lambda (combined u heavy and À light chain) concentration in human serum on the Siemens Behring Nephelometer™ II (BN™ II). The test result is to be used with previously diagnosed Waldenstoms Macrolobulinaemia in conjunction with other clinical and laboratory findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenstroms macrogibulinaemia.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for an IVD (In Vitro Diagnostic) device. It does not describe a study that uses AI or involves human readers, nor does it provide acceptance criteria and performance data in the structured format requested. Instead, it confirms the substantial equivalence of the "Hevylite™ Human IgM Kappa Kit" and "Hevylite™ Human IgM Lambda Kit" to legally marketed predicate devices.

The document focuses on:

  • Device Name: Hevylite™ Human IgM Kappa Kit and Hevylite™ Human IgM Lambda Kit for use on Siemens BN™ II Systems.
  • Intended Use: In vitro quantification of IgM Kappa and IgM Lambda concentrations in human serum using the Siemens Behring Nephelometer™ II (BN™ II). These results are to be used with previously diagnosed Waldenstroms Macroglobulinemia, in conjunction with other clinical and laboratory findings.
  • Limitation: The assay has not been established for the diagnosis, monitoring, and prognosis of Waldenstroms Macroglobulinemia.
  • Regulatory Information: Regulation number, name, class, product code, and a statement of substantial equivalence to predicate devices.

Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document, as it pertains to an IVD device approval and not an AI/ML-based diagnostic study.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).